Firm partner Robert E. Johnston to speak at 29th FDA Boot Camp on March 23, 2017.

March 23, 2017

External registration form.

Mr. Johnston will present "Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls."   Among the points that will be addressed during the discussion are:

  • What is pharmacovigilance?
  • How pharmacovigilance uses adverse event reports?

-Direct versus indirect reports
-Causality assessments
-Labeling changes
-Pre-and post-market ADE reporting requirements
-How regulatory agencies use ADE reports

  • Risk Evaluation and Minimization Strategies (REMS)
  • Risk evaluation in the approval process
  • Risk minimization tools
  • Enforcement of ADE reporting and REMS requirements
  • Examining the relevance to product liability risks, including innovator and co-promoter liability risks
  • What is the FDA’s recall and oversight authority (overview of 21CFR Part 7)?

-Guidance versus regulation
-Voluntary recalls versus mandatory recalls
-Market withdrawals and stock recoveries

  • Interaction between recalls and corrective and preventive action

Robert E. Johnston's practice focuses on trials and appeals of complex litigation matters, with an ‎emphasis on defending pharmaceutical product liability litigation and on prosecuting insurance ‎coverage disputes for corporate clients.  In 2015, he was selected by Corporate America Legal Elite for "Best in Product Liability Litigation-Washington, DC."

For more information and to register, please click on the link at the top of the page.